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A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

NCT00473512 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-03-27

Study results available
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Summary

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Abiraterone acetate

Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.

DRUG

Abiraterone acetate MTD

Abiraterone acetate MTD orally for 12 cycles (28 day each).

DRUG

Dexamethasone

Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473512 on ClinicalTrials.gov